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Regulatory and Compliance Manager – US – Chicago – 1293

Our client is one of the world leaders in the design, development and manufacturing of drug delivery devices. They cover all types of business models: from full solution development to pure contract manufacturing, through customized solutions. The company puts the patient first and develop all their products with the end user in mind. They have a strong culture of innovation and have developed unique proprietary products.

This is a new position as the company develops more IP products that will report to a VP located in Europe (Germany) with frequent travel (60%) to Europe (6-7 times per year) and across the US.

The main objectives of the position are:

Support ICD teams with regards to all Pharmaceutical, Medical device, Facility registrational and other Regulatory aspects (Regulatory Matrix, contact with customer on Regulatory aspects)

Support Production plants for regulatory aspects such as submission of DMFs (Drug Master File), preparation of 3.2.P.7, Regulatory Support for customers etc.

Support and/or Submission of Premarket Notifications (510k) in the USA and follow up

Assess and provide regular updates of the relevant regulations for registration aspects

Maintain the Regulatory and Compliance section of the internal communication tool

Propose global strategies for submission of the company products to support the marketing team

The main responsibilities are:

Develop and lead Regulatory Strategies for selected IP products and specific Projects

Ensure compliance of plants to facility or product registrations

Development of skills and training of a regulatory team with a matrix organization